Ethical issues regarding study designs used in serotonin-antagonist drug development

The time has come to develop new methods for the evaluation of antiemetic compounds. The well-established tenet that combination antiemetic therapy is superior to that achieved with any single agent for severely emetogenic cisplatin-containing chemotherapy does not warrant reevaluation with future cancer patients whenever a new antiemetic enters Phase II and III evaluation. New trials should instead focus on the more important issues of whether the new agent in combination offers comparable or superior efficacy to that achievable with the current standard antiemetic regimen for both acute and delayed nausea and vomiting. While proof of efficacy is crucial in drug trials, adequacy of patient care needs to be the first and foremost priority in any trial.

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				M. T Holdsworth and T. Vo-Nguyen Employment of Substandard Antiemetic Prophylaxis in Recent Trials of Chemotherapy-Induced Nausea and Vomiting Ann. Pharmacother., November 1, 2005; 39(11): 1903 - 1910. [Abstract] [Full Text] [PDF]